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Comparing a new biosimilar to Keytruda for lung cancer treatment

Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)

Phase 3 Interventional mAbxience Research S.L. · NCT06687369

This study is testing a new treatment called MB12 to see if it works as well as Keytruda for people with advanced lung cancer while possibly being more affordable.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment726 (estimated)
Ages18 Years and up
SexAll
SponsormAbxience Research S.L. Industry-sponsored
Drugs / interventionsipilimumab, pembrolizumab, chemotherapy
Locations151 sites (Yerevan and 150 other locations)
Trial IDNCT06687369 on ClinicalTrials.gov

What this trial studies

This study is a randomized, multicenter, multinational, double-blind trial designed to compare the pharmacokinetics, efficacy, safety, and immunogenicity of MB12, a proposed biosimilar to Pembrolizumab, against Keytruda® in patients with metastatic non-squamous non-small cell lung cancer (NSCLC). Participants will receive either MB12 or Keytruda® in combination with pemetrexed and platinum-based chemotherapy as their first-line treatment. The study aims to determine if MB12 can provide similar benefits to patients as the established treatment while potentially offering a more cost-effective option.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced stage IV non-squamous NSCLC who have not received prior systemic treatment.

Not a fit: Patients with predominantly squamous cell histology NSCLC or those who have received prior systemic treatment for metastatic NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more affordable treatment option that is as effective as the current standard therapy.

How similar studies have performed: Other studies have shown success with similar biosimilar approaches, indicating potential for this treatment to be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adult male/female patients ≥18 years old at the time of signing the informed consent form (ICF).
2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \[TNM\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.
3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.
4. Known status of PD-L1 expression.
5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.

Exclusion Criteria:

1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.
2. Known history of central nervous system metastases and/or carcinomatous meningitis.
3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).
4. Major surgery within 3 weeks of the first dose of study treatment.
5. Active autoimmune disease that has required systemic treatment in the last 2 years.
6. Contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.
7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.

Where this trial is running

Yerevan and 150 other locations

+101 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Squamous Non Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.